Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia
NCT ID: NCT02792985
Last Updated: 2016-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2015-08-31
2017-08-31
Brief Summary
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Participants will be randomised into either the experimental or control group. The experimental group will follow the multisensory stimulation intervention protocol, while the control group will follow the current hospital protocol.
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Detailed Description
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1. Experimental intervention protocol: occupation-based multisensory stimulation and the use of enriched environments;
2. Control intervention protocol: standard therapy as provided by the hospital which includes re-orientation and participation in basic functional tasks.
Participants: Approximately twenty participants will be recruited from the Institut Guttmann, which is a neuro-rehabilitation hospital in Badalona, Spain.
Measures:
The evaluation tools will consist of standardised, established assessments used in brain injury rehabilitation which are detailed in the Outcome Measures section.
Procedure:
Repeated measurements of behaviour and sensory motor function corresponding to the participant's progression of PTA assessment scores will be taken. The maximum number of times a single participant will be tested during PTA is 7 times and twice again following emergence from PTA, within the first 3 days and again after 1 week. All measurements are non-invasive and provide minimal adverse risks for the participant.
Participants will be randomised into either the Experimental or Control group. Participants, their family members, and the assessor taking outcome measures at the point of PTA resolution and one-month post-resolution will be blinded to group allocation and subsequent intervention protocol. Intervention provision will occur throughout the progression of PTA with post-intervention assessment to occur within 3 days of the end of PTA, one month after coming out of PTA, and through a follow-up questionnaire to be completed by the participant and family members at 6 months post-injury. All interventions are non-invasive and do not involve any risks above those that may be incurred through participation in the standard rehabilitation process.
The Experimental group will follow an intervention protocol involving transformation of the participant´s room into a sensory stimulating enriched environment (EE) and participation in occupation-based multisensory stimulation (OBMS) during their therapy sessions with an occupational therapist. They will receive two daily 30-minute individual therapy sessions.
The control group will follow the current protocol for patients in PTA at the Institut Guttmann. This includes one 30-minute individual therapy session or one hour group therapy session with an occupational therapist and minimal changes to their room (e.g. orientation board, photos of family and friends).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Multisensory stimulation protocol
The Experimental group will follow an intervention protocol.
Multisensory stimulation protocol
Participation in occupation-based multisensory stimulation (e.g. personal care with aromatic soaps, varying water temperatures and textured sponges, drink preparation of different flavoured beverages) with a variety of different sensory stimuli (e.g. strong smells, different shapes and weights). The participant will receive two individual 30-minute therapy sessions with an Occupational Therapist.
An enriched environment will be set up in the participant´s bedroom. It will include items that provide a range of meaningful sensory stimuli (e.g. familiar personal objects, projection of photos and known places, familiar music). The participant is encouraged to follow a timetable including regular rest breaks through out the day in their room.
Control protocol
The Control group will follow the current protocol for patients in PTA at the Institut Guttmann.
Control protocol
Retraining of basic activities of daily living or participation in table top tasks and games in an individual 30 minute session or a one hour small group session with an Occupational Therapist.
Minimal changes are made to the participant´s room (e.g. orientation board, photos of family and friends).
Interventions
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Multisensory stimulation protocol
Participation in occupation-based multisensory stimulation (e.g. personal care with aromatic soaps, varying water temperatures and textured sponges, drink preparation of different flavoured beverages) with a variety of different sensory stimuli (e.g. strong smells, different shapes and weights). The participant will receive two individual 30-minute therapy sessions with an Occupational Therapist.
An enriched environment will be set up in the participant´s bedroom. It will include items that provide a range of meaningful sensory stimuli (e.g. familiar personal objects, projection of photos and known places, familiar music). The participant is encouraged to follow a timetable including regular rest breaks through out the day in their room.
Control protocol
Retraining of basic activities of daily living or participation in table top tasks and games in an individual 30 minute session or a one hour small group session with an Occupational Therapist.
Minimal changes are made to the participant´s room (e.g. orientation board, photos of family and friends).
Eligibility Criteria
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Inclusion Criteria
* within 6 months of their initial brain injury
* in PTA (Levels of Cognitive Function 4-6)
* appropriate visual and auditory function to observe the environment and hear instructions with or without assistive aids
* independent use of one upper limb
Exclusion Criteria
* illness, diseases or alcohol or drug addiction that could affect cognitive function
* having a learning disability prior to injury
* participant is out of PTA
* visual, auditory, aphasic or motor disturbance that may interfere with the ability to complete the task or participate in the sessions
18 Years
80 Years
ALL
No
Sponsors
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The University of Queensland
OTHER
Institut Guttmann
OTHER
Responsible Party
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Principal Investigators
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Narda Murillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Guttmann
Locations
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Institut Guttmann
Badalona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014.205
Identifier Type: -
Identifier Source: org_study_id
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